EMEA-003439-PIP02-23 - paediatric investigation plan

GIPR antagonist/GLP-1R agonist (AMG 133)

Key facts

• Active Substance:
  GIPR antagonist/GLP-1R agonist (AMG 133)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0131/2024
• PIP number:
  EMEA-003439-PIP02-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/04/2024

Decision

P/0131/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for GIPR antagonist/GLP-1R agonist (AMG 133) (EMEA-003439-PIP02-23)

AdoptedReference Number: EMA/142616/2024